Project Call 1.0 Proposal Selected by NIIMBL Governing Committee

Durham, NC (USA) – August 30, 2018 – Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biotechnology industries, and the University of North Carolina Wilmington (UNCW), North Carolina’s globally-minded research and development university, today announce they have been awarded an educational grant from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), an organization comprised of companies, educational institutions, nonprofits, and state governments dedicated to accelerating biopharmaceutical manufacturing innovation, developing industry standards, and educating and training a pipeline of skilled workers for the field’s abundant well-paying jobs. The grant will fund the UNCW program “Partnership for Workforce Development in the Biopharmaceutical Industry,” which will be co-developed and taught by Alcami subject matter experts.

Name: Kourtney Mendieta
Alcami Site: Charleston, SC

How long have you been with Alcami?
I have been with the company for two years. 

What is your role? 
I am an Assistant Scientist I in the Microbiology laboratory. My team and I support sterile manufacturing operations and ensure sterility of our products. I also perform bioburden method suitability for new formulations to ensure our testing methods and materials are appropriate for the specific formulation. 

What is the most rewarding part of your job?
I find my career very rewarding because the work I perform everyday impacts someone's quality of life. I absolutely love being part of the Alcami team. The work we do is truly amazing, and I am so grateful I am able to be a part of it.  

Outsourcing highly potent active pharmaceutical ingredient (HPAPI) development and manufacturing is reaching an all-time high thanks to an increased demand of highly-targeted new drugs with greater efficacy at lower doses and the price of investment to handle internally. Several factors will dictate the performance of a contract development and manufacturing organization (CDMO) when handling HPAPIs. It is not merely a question of having the physical assets for high containment; outsourcing of a specialized and potentially challenging piece of the supply chain requires partnership and collaboration between the CDMO and sponsor. Any relationship is reliant upon transparency, team cohesion, and a level of experience that ensures a collaborative understanding with effective communication. Ultimately, success relies upon the equipment, experience, and a right-first-time ethos. Consider the factors discussed in this white paper when evaluating a potential CDMO partner.

According to the US Orphan Drug Act of 1983, a rare disease is defined as a condition that affects fewer than 200,000 people. The term orphan disease originated from pharmaceutical companies not having the resources to design and scale-up formulations to treat these diseases due to the lack of financial support for such highly specialized programs. The need for financial backing resulted in The Orphan Drug Act of 1983 that gave companies a means to develop treatments for rare diseases (NIH, 2017).

Rare diseases are caused by various reasons— most notably by genetics. However, the National Institutes of Health (NIH) states, “many rare diseases, including infections, some rare cancers, and some autoimmune diseases, are not inherited. While researchers are learning more each year, the exact cause of many rare diseases is still unknown” (NIH, 2017). Almost half of those affected by rare diseases are children (Global Genes, 2018).

The study of extractables and leachables is among the fastest-evolving disciplines in the pharmaceutical industry. Until recently, the primary focus of these studies has been components in direct contact with the drug product for extended periods, such as the primary packaging, or those that contact the formulation during administration, known as in-use componentry. However, the components used in manufacturing are of increasing interest as sources of potential leachables. Many components are single-use systems (SUS), polymeric in construction, and pre-treated prior to use. Each of these factors increase the potential for leachable compounds. In order to evaluate materials for potential leachable compounds, one must leverage a scientifically rigorous study design against the specific potential for drug product and packaging/surface interaction. 

Alcami will be presenting and exhibiting at CPhI Worldwide, to be held 9-11 October 2018 in Madrid, Spain. Be sure to visit Alcami in Hall 10 at booth 10D50 and connect with our team. 

Alcami is also delivering the following presentation: 

Signed into law on January 4, 1983, the Orphan Drug Act (ODA) allows for granting special status to a drug or biological product (drug) to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation, or orphan status. For a drug to qualify for orphan designation, both the drug and the disease or condition must meet certain criteria specified in the ODA and US Food and Drug Administration’s (FDA) implementing regulations per 21 CFR Part 316. The FDA Office of Orphan Products Development (OOPD) evaluates the scientific and clinical data submission from sponsors to identify and designate products as promising for rare diseases or conditions.

Alcami will be attending the 58th Annual Land O' Lakes Pharmaceutical Analysis Conference to be held August 6-9, 2018 in Madison, WI. Be sure to stop by our table and connect with our team to learn more about Alcami.

We will also be participating in the Poster Session on Wednesday, August 8, 2018 at 6:00pm. The poster is titled: The Future is Here: Elemental Impurities in Drug Products.

Name: Frank Nijnens
Alcami Site: Weert, Netherlands

How long have you been with Alcami?
I joined the company in August 2006.

What is your role? 
Within my project team I fulfill the role of Analytical Project Leader. I am responsible for safeguarding the timely development and quality of the needed analytical package to support the development of process routes and to support pilot plant campaigns, appropriate for the cGMP status of the project.

What is the most rewarding part of your job?
The joy of my work is meeting and exceeding expectations and overcoming challenges by combining all expertise within our project team (analytical, solid state, and organic chemistry). Knowing the strengths of each individual helps in solving analytical challenges within a condensed period of time. The positive feedback from our clients is the best recognition you can get.

Effective high containment API manufacturing has certain expectations and requirements; similarly, being a successful contract development and manufacturing organization (CDMO) has its own distinct challenges. When the demands of these two worlds meet, the ability to balance both offers a unique challenge.